Method for the selective sterilization of diagnostic test elements

Abstract

The invention concerns a method for producing integrated, diagnostic test elements ( 1 ) which have a lancing area ( 2 ) and a detection area ( 3 ). The lancing area is used to generate an opening in the skin and the detection area is used to detect an analyte in a body fluid. The selective sterilization sterilizes the lancing area but not the detection area by electron radiation. The method according to the invention comprises the steps of screening the detection area on the test element against electron radiation and subsequently irradiating the test element with electron radiation. The invention additionally concerns a method according to the invention in which the test elements and lancing areas are in a connected arrangement and are brought into the radiation area by moving the entire arrangement. Finally the invention concerns a diagnostic test element which has been produced according to the inventive method.

1. Method for producing integrated, diagnostic test elements which have a lancing area to generate an opening in the skin and a detection area to detect an analyte in a body fluid wherein the lancing area but not the detection area is sterilized by electron radiation, wherein the method comprises the steps
 screening the detection areas from electron radiation, wherein said screening includes packing the test elements in a package that has an integrated screen aligned with the detection areas of the test elements to screen the detection areas from the electron radiation; and subsequently 
 irradiating the integrated screen and the package with the electron radiation to sterilize the lancing areas of the test elements. 
 
     
     
       2. Method according to  claim 1 , further comprising:
 wherein the package includes a drum with a lower area coated with metal to act as the integrated screen; and 
 wherein said packing includes loading the test elements into the drum with the detection areas received in the lower area coated with the metal and the lancing areas extending past the lower area coated with the metal. 
 
     
     
       3. Method according to  claim 2 , wherein said packing further includes individually arranging in an axially symmetric manner the test elements in chambers inside the drum. 
     
     
       4. Method according to  claim 1 , further comprising:
 wherein the package includes a box; 
 wherein the screen includes a metal plate integrated into the box; and 
 wherein said packing includes stacking the test elements in a matrix-like manner within the box with the detection areas screened by the metal plate. 
 
     
     
       5. Method according to  claim 1 , further comprising:
 sealing the lancing area with a protection that prevents penetration of germs from the detection area and allows sterilization of the lancing area with electron radiation. 
 
     
     
       6. Method for producing integrated, diagnostic test elements which have a lancing area to generate an opening in the skin and a detection area to detect an analyte in a body fluid wherein the lancing area but not the detection area is sterilized by electron radiation, wherein the method comprises the steps
 sealing the detection area with a protective cover to create a barrier that prevents germs from the detection area from reaching the lancing area; 
 packing the test element into a package; 
 locating a radiation screen between the detection area of the test element and a source of electron radiation; 
 screening the detection area of the test element from electron radiation with the radiation screen; 
 irradiating the test element with the electron radiation after said screening; and 
 locating the radiation screen at a location other than between the detection area and the source of electron radiation after said irradiating. 
 
     
     
       7. Method according to  claim 6 , wherein said packing occurs before said screening. 
     
     
       8. Method according to  claim 6 , wherein said packing includes sealing the test element in a plastic foil. 
     
     
       9. Method according to  claim 6 , wherein said packing includes packing the test elements inside in the package without additional protection for the lancing area. 
     
     
       10. Method according to  claim 6 , wherein said packing includes packing includes individually packing the test element within a primary packaging. 
     
     
       11. Method according to  claim 10 , wherein said individually packing the test element within the primary package includes sealing the test element within an individual chamber within the primary packaging. 
     
     
       12. Method according to  claim 6 , wherein said screening permits electron radiation to sterilize the lancing area. 
     
     
       13. Method for producing integrated, diagnostic test elements which have a lancing area to generate an opening in the skin and a detection area to detect an analyte in a body fluid wherein the lancing area but not the detection area is sterilized by electron radiation, wherein the method comprises the steps
 sealing the detection area with a protective cover to prevent the escape of germs to the lancing area while the lancing area remains exposed; 
 packing the test element into a package; 
 screening the detection area of the test element from electron radiation; 
 irradiating the test element with the electron radiation after said screening; 
 sterilizing the outside of the protective cover with plasma treatment; 
 wherein the package includes a drum with a lower area coated with metal to act as the integrated screen; and 
 wherein said packing includes loading the test element into the drum with the detection area received in the lower area coated with the metal and the lancing area extending past the lower area coated with the metal. 
 
     
     
       14. Method for producing integrated, diagnostic test elements which have a lancing area to generate an opening in the skin and a detection area to detect an analyte in a body fluid wherein the lancing area but not the detection area is sterilized by electron radiation, wherein the method comprises the steps
 sealing the detection area in an air-tight manner with a protective cover to prevent the escape of germs to the lancing area while the lancing area remains exposed; 
 packing the test element into a package; 
 screening the detection area of the test element from electron radiation; 
 irradiating the test element with the electron radiation after said screening; 
 sterilizing the outside of the protective cover with plasma treatment; 
 wherein the package includes a box; 
 wherein the screen includes a metal plate integrated into the box; and 
 wherein said packing includes stacking a plurality of the test elements in a matrix-like manner within the box with the detection areas screened by the metal plate.